The FDA has issued final guidance regarding implementation of the Drug Supply Chain Security Act (DSCSA), legislation passed in 2013, which outlines steps to build an electronic, interoperable system over the next 10 years that will identify and trace certain prescription drugs as they are distributed within the US. DCAT Value Chain Insights examines what is involved in the latest guidance.
A key component of the DSCSA is to encourage heightened vigilance and awareness among supply-chain partners, including improving detection and removal of potentially dangerous drugs from the supply chain.The new guidance identifies specific scenarios that could increase the risk of a suspect product entering the pharmaceutical distribution supply chain and provides recommendations on how trading partners can identify such products.
Inside the DSCSA
Under the DSCSA, tracing and serialization requirements first took effect with the passage of the law on November 27, 2013, and then are staged for implementation with some requirements taking effect January 1, 2015 and others taking effect four years after enactment, and a new “Phase II” occurring 10 years after enactment. The requirements will require use of a product identifier: a GS-1-compliant standardized graphic that includes, in both human-readable form and on a machine-readable data carrier: the standardized numerical identifier, lot number, and expiration date of the product.
The requirements of DSCSA apply to the following: manufacturers (i.e, holder of a new drug application (NDA) or abbreviated new drug application (ANDA), a co-licensed partner, or an affiliate of the NDA/ANDA holder or co-licensed partner); repackagers; wholesale distributors; third-party logistics providers (which are subject to licensure provisions); and dispensers (e.g., pharmacies and healthcare providers). The traceability requirements generally apply to the transaction (the transfer of product between persons in which a change of ownership occurs) and the product (prescription drugs in finished dosage form intended for human use). With respect to that transaction between parties, the law outlines requirements for the transaction information, transaction history, and transaction statement.
Phase I of implementation of the DSCSA began with the passage of the law on November 27, 2013, which locked in federal pedigree requirements. The DSCSA also immediately created “floor and ceiling” preemption with respect to state and local laws related to the tracing of products through the distribution system that are inconsistent, more stringent, or in addition to the DSCSA requirements.
The next phase of implementation began in January 1, 2015 and imposed important requirements. First, entities must trade with only authorized trading partners (i.e, manufacturers; wholesale distributors; third-party logistics providers; and dispensers). Entities also must pass, capture, and maintain the transaction history, transaction information, and transaction statement; the exception is that dispensers were given until July 1, 2015 to comply. Entities must also respond to requests for information and have systems and processes to investigate, verify, and respond to suspect and illegitimate products. Four years after enactment (November 27, 2017), manufacturers must pass the transaction history, transaction statement, and transaction information in electronic form, serialize product, and meet enhanced verification requirements. In each succeeding year, repackagers, wholesale distributors, and dispensers respectively must comply with similar requirements.
Earlier this month, the US Food and Drug Administration (FDA) issued final guidance, Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification, one of a series of FDA guidances on DSCSA implmentation. As of January 1, 2015, a trading partner that determines a product in its possession or control is an illegitimate product must notify the FDA and certain immediate trading partners as specified by the DSCSA. Manufacturers are additionally required to notify the FDA and certain immediate trading partners after the manufacturer determines or is notified by FDA or a trading partner that there is a high risk that a product is illegitimate. This new guidance identifies specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain; provides recommendations on how trading partners can identify a product and determine whether a product is a suspect product as soon as practicable; and sets forth the process by which trading partners should notify the FDA of illegitimate product or products with a high risk of illegitimacy, and how they must terminate the notifications, in consultation with the FDA.
This new guidance does not address all provisions of the DSCSA related to suspect and illegitimate products. As FDA works to implement other provisions of the DSCSA, the agency intends to issue additional information to support efforts to develop standards, issue guidance and regulations, establish pilot programs, and conduct public meetings.
The new guidance also offers recommendations for trading partners on ways that they can expeditiously identify suspect product and determine whether the product is suspect (and, after investigation, whether it is illegitimate). In general, the guidance advises that trading partners should exercise due diligence when conducting business and should confirm that all trading partners are authorized. It notes that trading partners should discuss with each other any observations, questions, or concerns they have related to the status of a drug as a suspect product to aid them in determining whether the drug should be considered a suspect product. The guidances notes that trading partners should also contact regulatory authorities, law enforcement, the drug’s manufacturer, or other available resources to aid in that determination when additional expertise is called for to make an accurate assessment of the status of a drug as a suspect product. If a trading partner receives a product in a secured transport container or sealed homogenous case, trading partners should examine the appearance of that container, says the guidance. If trading partners observe anything suspicious, they should take steps to ascertain whether the product inside the transport container is suspect. The guidances offers specific strategies or approaches to help make that determination.